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Title:  Analyst, Quality Control Development

Date:  Oct 3, 2025
Location:  Sun Pharma Canada Inc.
Company:  Sun Pharma Canada Inc.

Job purpose

 

The main responsibility for this position is to perform method development, validation and transfer activities to support quality control development department.

 

Duties and responsibilities

 

  • Perform Assay and Related Substances method development and validation study using HPLC, GC and other instrumental techniques.
  • Ensure timely completion of routine analysis for bulk, finished products, exhibit batches, and stability samples.
  • Prepare protocol, test method and report related with method validation and method transfer studies.
  • Conduct method verification, compendial update & method transfer activities.
  • Identify and implement key process improvements to enhance systems, improve efficiency, and meet GMP requirements.
  • Ensure Out-of-Specification (OOS), Out-of-Trend (OOT), and Corrective and Preventive Actions (CAPAs) are completed within defined timelines.
  • Collaborate cross-functionally to proactively build quality into processes and systems.
  • Create and revise Quality Control (QC) procedures as required.
  • Provide support during internal and regulatory Inspections.
  • Generate, compile and analyze data for reporting purposes.
  • Complete all GMP documentation correctly and in a timely manner.
  • Initiate and follow through on actions required to close change controls.
  • Participate in Internal, customer and regulatory audits.
  • Maintain a clean and safe laboratory environment, adhering to all safety regulations. 
  • Complete all assigned training and maintain up-to-date personal training records.
  • Demonstrate flexibility to work shift schedules as required.
  • Support peer review of analytical data.
  • Contribute to new product launches.
  • Perform other duties as assigned by the manager.

 

Additional responsibility (Only applicable to customer facing roles)

 

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

 

Qualifications

 

  • Bachelor’s Degree in Chemistry or a related discipline (minimum requirement).
  • 5-7 year of experience in Assay & Impurities method validation in a pharmaceutical laboratory.
  • Expert knowledge of analytical chemistry and instrumentation.
  • Proficiency in analytical techniques such as UV-Vis, IR, HPLC and GC.
  • Familiarity with software systems including LIMS, Empower, and Microsoft Office.
  • Strong understanding and application of Health Canada and FDA regulations.
  • Excellent written communication and report writing skills.
  • Advanced troubleshooting and investigative skills for analytical issues.
  • Ability to recommend changes and initiate investigations when necessary.
  • Recommends changes and requests investigations where required.
  • Knowledge of In-Vitro & Cleaning validation study is considered an asset

 

 

Working conditions

 

  • Ability to work under stressful conditions and changing priorities
  • Ability to support work in other shifts
  • Numerous and varied responsibilities demanding attention and detail
  • Working in general office and laboratory environments

 

Physical requirements

 

Office based

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